Miricorilant for Healthy Subjects

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Corcept Therapeutics

Must not be taking: Glucocorticoids, others

Disqualifiers: Cardiovascular, Renal, Hepatic, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 periods with washout

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on studying a drug called miricorilant in healthy individuals. Researchers aim to determine how different tablet forms of the drug are absorbed by the body. Participants will receive doses of miricorilant in specific sequences across several periods, with breaks in between. The trial seeks healthy men or women who are not pregnant and weigh at least 50 kg (about 110 pounds). As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I need to stop taking my current medications to join the trial?

Yes, you need to stop taking any prescribed or over-the-counter drugs, vitamins, or herbal remedies at least 14 days before the trial starts.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that miricorilant is generally well-tolerated. In one study, most participants did not experience serious side effects while taking miricorilant. Although some minor side effects occurred, they were uncommon. Another study compared miricorilant to a placebo (a pill with no active medicine) and found similar safety levels for both, suggesting that miricorilant does not cause more issues than a placebo.

As this is an early phase study, the primary goal is to assess the treatment's safety for participants. Early phase trials typically involve small groups, allowing researchers to closely monitor any side effects. While there is limited information on long-term safety, early results appear promising. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Miricorilant because it offers a new approach by targeting cortisol activity, which is different from most current treatments that manage cortisol levels indirectly. Unlike traditional options, which are often medications like glucocorticoids or cortisol synthesis inhibitors, Miricorilant directly modulates the body's response to cortisol, potentially providing more precise control. This unique mechanism could lead to better outcomes with fewer side effects, making it a promising option for managing conditions related to cortisol imbalance.

What evidence suggests that this trial's treatments could be effective?

Research has shown that miricorilant can greatly reduce liver fat. In earlier studies, patients quickly experienced significant decreases in liver fat. One study even reported a complete improvement in a patient's liver imaging. Miricorilant specifically targets certain pathways in the body that help manage liver disease. These findings suggest it could be effective, but further research is needed to confirm this. Participants in this trial will receive miricorilant in various treatment sequences to further evaluate its effects. ^{6 7 8 9 10}

Who Is on the Research Team?

Joseph Custodio, PhD

Principal Investigator

Corcept Therapeutics

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study to compare different tablet formulations of a drug called miricorilant. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

Able to understand written informed consent

Willing and able to comply with study requirements

Willing to comply with protocol-specified contraception requirements

Exclusion Criteria

History or evidence of hypokalemia

Serious adverse reaction or hypersensitivity to any drug or formulation excipients

History of clinically significant allergy requiring treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods, with a washout period of at least 7 days following each dose.

3 periods with washout

3 visits (in-person)

Optional Treatment

After completion of Period 3, selected participants may receive a single dose of treatment D in a fasted state on Day 1 of Period 4.

1 period

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including clinical laboratory findings.

72 hours postdose in periods 3 and 4

What Are the Treatments Tested in This Trial?

Interventions

• Miricorilant

Trial Overview The study is testing the bioavailability (how well the body absorbs and uses) of two miricorilant tablet formulations, labeled as Treatment A, B, C, and D. Participants will receive these treatments in varying sequences to compare their effects.

How Is the Trial Designed?

Group I: Optional Miricorilant Treatment D Experimental Treatment 1 Intervention

After completion of Period 3, analysis of pharmacokinetic and safety data will be used to decide if Period 4 will be conducted. In Period 4, selected participants will receive a single dose of treatment D in a fasted state on Day 1.

Group II: Miricorilant Treatment Sequence C, B, A Experimental Treatment 3 Interventions

Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment B; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug.

Group III: Miricorilant Treatment Sequence C, A, B Experimental Treatment 3 Interventions

Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment A; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug.

Group IV: Miricorilant Treatment Sequence B, C, A Experimental Treatment 3 Interventions

Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B, in Period 2, treatment C; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug.

Group V: Miricorilant Treatment Sequence B, A, C Experimental Treatment 3 Interventions

Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B; in Period 2, treatment A; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug.

Group VI: Miricorilant Treatment Sequence A, C, B Experimental Treatment 3 Interventions

Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment C; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug.

Group VII: Miricorilant Treatment Sequence A, B, C Experimental Treatment 3 Interventions

Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment B; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug.

Who Is Running the Clinical Trial?

Corcept Therapeutics

Lead Sponsor

Trials

72

Recruited

7,700+

Dr. Joseph K. Belanoff

Corcept Therapeutics

Chief Executive Officer since 2014

MD from Stanford University

Dr. William Guyer

Corcept Therapeutics

Chief Medical Officer since 2021

PharmD

Citations

1. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/full/10.1002/jcph.70113

The Journal of Clinical Pharmacology - Wiley Online Library In phase 1 clinical studies in healthy subjects, miricorilant showed an approximately dose-proportional increase in systemic exposure in the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41014112/

Evaluation of the Pharmacokinetics, Disposition, and ... In phase 1 clinical studies in healthy subjects, miricorilant showed an approximately dose-proportional increase in systemic exposure in the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07240116

Study Evaluating the Bioavailability of Miricorilant With ... This study will consist of 6 possible treatment sequences across 3 periods for healthy, fed participants. A fourth period may be added to assess ...

4. corcept.com corcept.com/wp-content/uploads/AASLD2021-poster-04112022-updated2.pdf

Miricorilant, a selective GR Treatment with miricorilant resulted in large, rapid reductions in liver fat content (LFC). • One patient experienced complete radiologic.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05117489?cond=NASH%20-%20Nonalcoholic%20Steatohepatitis&viewType=Table&rank=2

NCT05117489 | A Study Evaluating the Safety, Efficacy, ... This phase 1b, Open-Label Study will assess the safety, efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03823703

NCT03823703 | Study Evaluating the Safety, Efficacy, and ... This is a randomized, double-blind, placebo-controlled study that assessed the safety efficacy and pharmacokinetics (PK) of miricorilant in patients with ...

7. sigmaaldrich.com sigmaaldrich.com/AU/en/product/achemblock/advh9b9b390c?context=bbe&srsltid=AfmBOoqfGa-I81zzuyDoN-oMW3xQdU8EkbxNjXWZlSzBJ9moOlHYHGh4

Miricorilant | 1400902-13-7 Safety Information · Pictograms · Signal Word · Hazard Statements · Precautionary statements · MSDS.

8. corcept.com corcept.com/publications/monarch-a-phase-2b-randomized-double-blind-placebo-controlled-study-evaluating-the-efficacy-and-safety-of-miricorilant-in-adult-patients-with-metabolic-dysfunction-associated-steatohepatitis-mash/

MONARCH: a Phase 2b, Randomized, Double-Blind ... MONARCH: a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8575171/

Effect of Miricorilant, a Selective Glucocorticoid Receptor ... Information on safety and tolerability was also obtained, and we included a comparison of the effects of miricorilant and placebo on the incidence and degree of ...

10. medchemexpress.com medchemexpress.com/miricorilant.html?srsltid=AfmBOop7ZfToZWFuLiYNA6KXB-jjNnladMc2VoGMOrxVaCZRnw9tsr4q

Miricorilant (CORT 118335) | GR Modulator/MR Antagonist SAFETY DATA SHEET (SDS). Request for HNMR Report. We have received your request and will respond to you as soon as possible. [e-mail]; 609-228 ...